CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58 enrolled
Drug / intervention
ezetimibe +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Age 18-70 years
  • ✓Primary hypercholesterolemia with moderately high cholesterol
  • ✓Otherwise healthy
Key exclusion· 3
  • ✕Current use of statins (must discontinue ≥6 weeks before study drug)
  • ✕Current use of fibrates (must discontinue ≥8 weeks before study drug)
  • ✕Use of other lipid-lowering medicines

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00101439
NCT00101439Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, 2-Period, Crossover Study to Evaluate the Effects of Ezetimibe on the Postprandial Lipoprotein Response in Patients With Primary Hypercholesterolemia

Organon and Co·interventional·Posted Jan 11, 2005·Updated Jun 18, 2024

In Brief

A Phase 3 clinical trial evaluating ezetimibe and Comparator: placebo for Hypercholesterolemia. Completed, enrolled 58 participants.

Detailed Summary

A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the cholesterol concentration of the chylomicron-containing Sf≥400 fraction following a cholesterol-enriched test meal.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2005
Enrollment StartNov 10, 2005
Primary CompletionOct 24, 2006
Study CompletionNov 8, 2006
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 21.5 years ago

Interventions

ezetimibedrug

Comparator: placebodrug